Hitachi Medical Systems America Inc

FDA recalling firm · 15 enforcement events · 17 product records · 2012–2021 · OH

Hitachi Medical Systems America Inc has 15 FDA enforcement events on this register (17 product records) between 2012 and 2021: 15 device; the busiest year was 2017 with 3.

0% of its events are Class I; the most common class is Class II (15). 0 events are listed as ongoing; the recalling firm's address is in OH.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
1 Mar 2021	Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic,…	Device	Class II	1	Terminated
31 Jan 2020	UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.	Device	Class II	1	Terminated
16 Oct 2019	Hitachi Scenaria Whole-body X-ray CT System	Device	Class II	1	Terminated
29 Jun 2018	Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA can be post…	Device	Class II	1	Terminated
18 Jun 2018	Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved…	Device	Class II	1	Terminated
20 Oct 2017	Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.	Device	Class II	1	Terminated
2 May 2017	Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.	Device	Class II	1	Terminated
6 Jan 2017	Hitachi Oasis MRI System - C-Spine Coil	Device	Class II	1	Terminated
30 Jun 2015	Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087	Device	Class II	1	Terminated
16 Apr 2015	Hitachi Oasis MRI System	Device	Class II	3	Terminated
18 Aug 2014	Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.	Device	Class II	1	Terminated
25 Apr 2014	Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal,…	Device	Class II	1	Terminated
31 Jan 2013	Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems…	Device	Class II	1	Terminated
15 Jun 2012	Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.	Device	Class II	1	Terminated
4 May 2012	Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide…	Device	Class II	1	Terminated

By type and class

Device15

Class II15

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Hitachi Medical Systems America Inc by year initiated.

Questions and answers

How many FDA recalls has Hitachi Medical Systems America Inc had?

15 enforcement events (17 product records) on this register, 2012–2021: 15 device.

Are any Hitachi Medical Systems America Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Hitachi Medical Systems America Inc recalls?

15 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.